SOURCES SOUGHT
A -- Identification of Sources with a Plague Vaccine Candidate Product for Participation in a Phase I Clinical Trial and Possible Future Production
- Notice Date
- 2/26/2004
- Notice Type
- Sources Sought
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- W9113M-04-R-0000
- Response Due
- 3/26/2004
- Archive Date
- 5/25/2004
- Point of Contact
- Lynn Selfridge, 301-619-2707
- E-Mail Address
-
US Army Space and Missile Defense Command, Deputy Commander
(lynne.selfridge@smdc.army.mil)
- Small Business Set-Aside
- N/A
- Description
- The Joint Vaccine Acquisition Project Office (JVAP) seeks to identify qualified, responsible sources for participation in a Foreign Comparative Testing (FCT) project for a plague vaccine to protect against pneumonic plague caused by exposure to aeros olized plague threat agent. For a source to be determined qualified and responsible to participate it must meet the following requirements: 1. The source must have a vaccine candidate (test articles) ready for a Food and Drug Administration (FDA) Phase 1 clinical trial involving at least 40 human subjects no later than March 1, 2005, and 2. the vaccine candidate (test articles) must be other than the F1-V fusion protein candidate, which is already in development. JVAP will not fund any development work t o fulfill the first requirement. Qualified sources should provide evidence to substantiate that the mandatory requirements have been met, e.g., identification of antigens, adjuvants, and proposed formulation, the name of the production facility for bulk d rug substance, results of any product release testing done, and copies of any relevant written communication involving the FDA. Written communication with the FDA could be a request for a pre-Investigational New Drug (IND) meeting, a response to a request for pre-IND meeting, an IND submission to the FDA, or an FDA response to an IND submission. JVAP intends to provide the qualified sources responding to this announcement a solicitation for test articles to be used in the Phase 1 clinical trial. At the c onclusion of the Phase 1 clinical trial, the product that best meets user needs shall continue on with the effort to obtain the FDA license. Therefore, the solicitation will also include priced options for the conduct of additional clinical trials, other licensure-enabling activities, the procurement of optional quantities of up to 10 million troop-equivalent doses (TED) to be delivered between fiscal year (FY) 2009 â FY 2010, and optional annual procurement of up to 10 million TED thereafter for 10 y ears. This sources sought announcement is open to all sources, both foreign and domestic. Sources must comply with the requirements of this synopsis within 30 calendar days of publishing in the FEDBIZOPS to be considered. Information should be provided electronically to Ms. Susan Dell, contract specialist, at susan.dell@u.s.army.mil. The technical point of contact is Dr. Cliff Snyder at cliff.snyder@u.s.army.mil. Only those sources responding to this synopsis shall be eligible for contract award.
- Web Link
-
Link to FedBizOpps document.
(http://www.eps.gov/spg/USA/SMDC/DASG60/W9113M-04-R-0000/listing.html)
- Place of Performance
- Address: US Army Space and Missile Defense Command, Chemical and Biological Operations Branch ATTN SMDC-CM-CB, 64 Thomas Johnson Drive, Third Floor Frederick MD
- Zip Code: 21702-5014
- Country: US
- Zip Code: 21702-5014
- Record
- SN00532225-F 20040228/040226234019 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
(may not be valid after Archive Date)
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